Question 1

Who is the manufacturer of PDS POLYDIOXANONE MESH?

Accepted Answer

ETHICON, Inc. filed the 510(k) submission for PDS POLYDIOXANONE MESH (K844228).

Question 2

What is the FDA product code for PDS POLYDIOXANONE MESH?

Accepted Answer

FTM. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was PDS POLYDIOXANONE MESH cleared by the FDA?

Accepted Answer

Jan 24, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for PDS POLYDIOXANONE MESH?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like PDS POLYDIOXANONE MESH?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K844228
Device Name	PDS POLYDIOXANONE MESH
Applicant	ETHICON, Inc.
Product Code	FTM · General, Plastic Surgery
Decision Date	Jan 24, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2

PDS POLYDIOXANONE MESH

Device Facts

Regulatory Classification

Identification